Granisetron Hydrochloride Oral Suspension
DEFINITION
Granisetron Hydrochloride Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled content of granisetron hydrochloride (C18H24N4O·HCl). Prepare Granisetron Hydrochloride Oral Suspension (0.056 mg/mL) equivalent to 0.05 mg of Granisetron per mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 
795
).
795). | Granisetron (as Hydrochloride) | 5 mg (5.6 mg) |
| Vehicle: A mixture of Vehicle for Oral Solution, NF, and Vehicle for Oral Suspension, NF, (1:1), a sufficient quantity to make | 100 mL |
Calculate the required quantity of each ingredient for the total amount to be prepared. If using tablets, place the required number of tablets in a suitable mortar, and comminute the tablets to a fine powder with a pestle, or add Granisetron Hydrochloride powder. Add the Vehicle in small portions, and triturate to make a smooth paste. Add increasing volumes of the Vehicle to make a Granisetron Hydrochloride suspension that is pourable. Transfer the contents of the mortar, stepwise and quantitatively, to a calibrated bottle. Add enough Vehicle to bring to final volume, and mix well.
ASSAY
• Procedure
Mobile phase:
Acetonitrile and 50 mM monobasic sodium dihydrogen phosphate (3:17). Adjust with phosphoric acid to a pH of 7.0. Make adjustments if necessary (see Chromatography 621, System Suitability.)
621, System Suitability.)
Standard stock solution:
1.0 mg/mL USP Granisetron Hydrochloride RS
Standard solution:
Transfer 2.5 mL of Standard stock solution to a 100-mL volumetric flask, and dilute with Mobile phase to volume to obtain a solution containing 25 µg/mL of granisetron hydrochloride.
Sample solution:
Shake the Oral Suspension thoroughly by hand. Pipet 5.0 mL into a 10-mL volumetric flask. Dilute with Mobile phase to volume, and mix to obtain a nominal concentration of 25 µg of granisetron hydrochloride/mL.
Chromatographic system
Mode:
LC
Detector:
UV 300 nm
Column:
4.6-mm × 15-cm; 5-µm packing L10
Flow rate:
1.0 mL/min
Injection size:
20 µL
System suitability
Sample:
Standard solution
[Note—The retention time of the granisetron peak is 7.0 min. ]
Suitability requirements
Relative standard deviation:
NMT 2.0% for the replicate injections
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of C18H24N4O·HCl in the volume of Oral Suspension taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of granisetron hydrochloride in the Standard solution (µg/mL) |
| CU | = | = nominal concentration of granisetron hydrochloride in the Sample solution (µg/mL) |
Acceptance criteria:
90.0%–110.0%
SPECIFIC TESTS
• pH 791:
4.0–4.5
791:
4.0–4.5
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Package in tight, light-resistant containers. Store at controlled room temperature or controlled cold temperature.
• Labeling:
Label it to state that it is to be well shaken before use, and to state the Beyond-Use Date.
• Beyond-Use Date:
NMT 90 days after the date on which it was compounded when stored at controlled room temperature or when stored at controlled cold temperature
• USP Reference Standards 11
11
USP Granisetron Hydrochloride RS
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Jeanne H. Sun
Assistant Scientific Liaison 1-301-816-3361 |
(CMP2010) Compounding |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 3375
Pharmacopeial Forum: Volume No. 34(6) Page 1454